Identity
- Trade Name
- Preat Implant Prosthetics FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- ASC Astra® EV-compatible 4.8mm Titanium Screw FDA UDI
- Model / Reference
- 9006754 FDA UDI
- Description
- ASC Astra® EV-compatible 4.8mm Titanium Screw FDA UDI
Identifiers
- Catalog Number
- 9006754 FDA UDI
- Primary DI / UDI-DI
- 00842092159187 FDA UDI
- 510(k) Number
- K220823 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental prosthesis/implant abutment screw
Preat Implant Prosthetics by PREAT Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental prosthesis/implant abutment screw.
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- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
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- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
- Recharge Kit w/ POC, TiLobe — SMART DENTURE CONVERSIONS, LLC · Class I
Cleared under the same submission
K220823 also covers:
- Implant Prosthetics — PREAT Corporation
- Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
- Preat Implant Prosthetics — PREAT Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PREAT Corporation
Sources (1)
- FDA UDI b4485920-f9cc-46f5-a28b-93c0b4b8bd44 36 fields · synced Jun 1, 2026